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our Premium Content: News alerts, weekly reports and conference plannersDRUG:
cibisatamab (RG7802)
i
Other names: RG7802, RG-7802, RO6958688, CEA-TCB, RO 6958688, RO-6958688, CEA-CD3 TCB, WHO 10636
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Company:
Roche
Drug class:
CD3 agonist, CEA inhibitor
Related drugs:
10d
CEA-4-1BBL: CEACAM5-Targeted 4-1BB Ligand Fusion Proteins for Cis Co-Stimulation with CEA-TCB. (PubMed, Antibodies (Basel))
For the assessment of the combination of CEA-TCB with CEA-4-1BBL, co-stimulatory antibody fusion protein in vitro assays are not sufficient to fully capture the complex relationships affecting efficacy. Thus, screening with different cell assays and in vivo efficacy studies in combination with CEA-TCB are essential to select the best candidate. Based on the totality of data on the T84.66-LCHA-4-1BBL antibody fusion protein comprising the CEACAM5 antibody, T84.66-LCHA was selected as the optimal combination partner for CEA-TCB.
Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
cibisatamab (RG7802)
1m
Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
P1/2, N=314, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Nov 2026 --> Nov 2025
Trial completion date
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PD-L1 (Programmed death ligand 1)
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PD-L1 expression
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
5ms
BP42675: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1, N=54, Completed, Hoffmann-La Roche | Phase classification: P1/2 --> P1
Phase classification
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CEACAM5 (CEA Cell Adhesion Molecule 5) • CSF2 (Colony stimulating factor 2)
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Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
10ms
In Vitro Evaluation of the Safety and Efficacy of Cibisatamab Using Adult Stem Cell-Derived Organoids and Colorectal Cancer Spheroids. (PubMed, Cancers (Basel))
This highlights our model's potential to predict clinical immunotherapy outcomes, capturing complex responses like immune activation, therapeutic selectivity, and potential resistance mechanisms. These findings underscore the utility of our model as a reliable, physiologically relevant tool for screening new immunotherapies and advancing our understanding of tumor-immune dynamics.
Preclinical • Journal • IO biomarker
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CEACAM5 (CEA Cell Adhesion Molecule 5) • GZMB (Granzyme B)
|
cibisatamab (RG7802)
11ms
BP42675: Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=54, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed | N=80 --> 54
Trial completion • Enrollment change
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
11ms
Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
P1/2, N=314, Active, not recruiting, Hoffmann-La Roche | N=675 --> 314
Enrollment change
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
over1year
A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov)
P1, N=47, Terminated, Hoffmann-La Roche | Completed --> Terminated; The Sponsor terminated the study because development of cibisatamab has been discontinued.
Trial termination • Combination therapy • Metastases
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MSI (Microsatellite instability) • CEACAM5 (CEA Cell Adhesion Molecule 5)
|
Tecentriq (atezolizumab) • Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • cibisatamab (RG7802)
over1year
Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
P1/2, N=675, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Jun 2026 --> Sep 2025 | Recruiting --> Active, not recruiting | Trial completion date: Sep 2027 --> Nov 2026
Enrollment closed • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • Repatha (evolocumab) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
over1year
CEA-CD3 bispecific antibody cibisatamab with or without atezolizumab in patients with CEA-positive solid tumours: results of two multi-institutional Phase 1 trials. (PubMed, Nat Commun)
Cibisatamab is a bispecific antibody-based construct targeting carcinoembryonic antigen (CEA) on tumour cells and CD3 epsilon chain as a T-cell engager. ADA appearance could be mitigated by obinutuzumab-pretreatment, with 8% of patients having persistent ADAs. Overall, cibisatamab warrants further exploration in immunotherapy combination strategies for MSS-CRC.
P1 data • Clinical Trial,Phase I • Journal
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CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 positive
|
Tecentriq (atezolizumab) • Gazyva (obinutuzumab) • cibisatamab (RG7802)
over1year
A Phase Ib Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Cibisatamab in Combination With Atezolizumab After Pretreatment With Obinutuzumab in Participants With Previously Treated Metastatic Colorectal Adenocarcinoma (clinicaltrials.gov)
P1, N=47, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed
Trial completion • Combination therapy • Metastases
|
MSI (Microsatellite instability) • CEACAM5 (CEA Cell Adhesion Molecule 5)
|
Tecentriq (atezolizumab) • Gazyva (obinutuzumab) • Actemra IV (tocilizumab) • cibisatamab (RG7802)
over1year
Study To Evaluate Safety, Pharmacokinetics, Pharmacodynamics, And Preliminary Anti-Tumor Activity Of RO7122290 In Combination With Cibisatamab With Obinutuzumab Pre-Treatment (clinicaltrials.gov)
P1/2, N=80, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Jul 2025 --> Dec 2024 | Trial primary completion date: Jul 2025 --> Dec 2024
Trial completion date • Trial primary completion date • Combination therapy • Metastases
|
CEACAM5 (CEA Cell Adhesion Molecule 5)
|
CEACAM5 expression • CEACAM5 overexpression
|
Gazyva (obinutuzumab) • RG7827 • cibisatamab (RG7802)
almost2years
Morpheus Lung: A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) (clinicaltrials.gov)
P1/2, N=675, Recruiting, Hoffmann-La Roche | N=470 --> 675 | Trial completion date: Nov 2026 --> Sep 2027 | Trial primary completion date: Aug 2025 --> Jun 2026
Enrollment change • Trial completion date • Trial primary completion date • Metastases
|
PD-L1 (Programmed death ligand 1)
|
PD-L1 expression
|
Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • docetaxel • Cotellic (cobimetinib) • pemetrexed • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Actemra IV (tocilizumab) • tiragolumab (RG6058) • camonsertib (RP-3500) • cibisatamab (RG7802) • ciforadenant (CPI-444) • zanzalintinib (XL092)
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